SERTRALINE HYDROCHLORIDE (Page 16 of 16)

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SERTRALINE HYDROCHLORIDE sertraline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-4029(NDC:16729-217)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SERTRALINE HYDROCHLORIDE (SERTRALINE) SERTRALINE 100 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
HYDROXYPROPYL CELLULOSE (TYPE L)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (5 MPA.S)
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
POLYSORBATE 80
FERRIC OXIDE YELLOW
Product Characteristics
Color yellow Score 2 pieces
Shape ROUND (Biconvex) Size 9mm
Flavor Imprint Code S3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68071-4029-2 28 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68071-4029-3 30 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:68071-4029-6 60 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:68071-4029-9 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202825 02/09/2017
Labeler — NuCare Pharmaceuticals,Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals,Inc. 010632300 repack (68071-4029)

Revised: 07/2022 NuCare Pharmaceuticals,Inc.

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